MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HIP KIT

Model Number N/A

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Material Rupture (1546); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

The product will not be returning to the manufacturer for evaluation; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It was initially reported that the battery of the pulsavac system exploded in the operating room.There was a bang and powder has leaked from the battery bay.The device was stored in the operating room; temperature was normal.The system has exploded as it was not used.Additional information was received on jul 27, 2016 stating that the event occurred after surgery and there was no medical intervention/additional surgical procedure required.Clarification provided on jul 28, 2016 stated that after the surgery, the user had cut the cable so that the used power packs can be stored better.The damage of the packs took place only after the customer had cut the cable with scissors, thereby causing a short circuit.

Manufacturer Narrative

The device history records (dhr) review was not performed for the part number 00515048201 hip kit pulsavac.The production trace lot number was not reported and is unknown.The customer discarded the device after use.No product returned for evaluation.However, the customer did provide photographs.The photos display that the electrical cable had been severed and that the battery pack sustained damage due to anode expulsion including release of battery content.The photographs confirm the reported event.The customers reported event is: ¿battery of pulsavac system has exploded in the operating room.There was a bang and powder has leaked from the battery bay.¿ this reported event was confirmed using the customer supplied photographs.The review of the manufacturing, testing and inspection processes noted no systemic issues.In addition, each device is operationally tested multiple times in production before packaging.The instructions for use list several situations that can cause a major electrical short in the battery pack.Cutting the wire with the batteries still in place can cause a catastrophic electrical short initiating anode expulsion of the batteries.The cause for this incident is improper disposal of the device in contradiction of the ifu warnings by the customer.The device ifu and the labeling on the tyvek lid warn that cutting the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire or personal injury.The batteries should be physically removed from the battery pack, care should be taken and personal safety equipment should be worn.The instructions for use explicitly states: warnings: explosion hazard.Do not use in presence of flammable anesthetics or gases.Do not submerge handle in liquid as this may compromise the efficiency of the pump or alter the ph of the liquid.Do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.Do not submerge the battery pack in liquid.Additionally, the tyvek lid for the individual pulsavacs devices states: warning: explosion hazard.Do not use in presence of flammable anesthetics or gases.Do not submerge in liquid as this may compromise the efficiency of the pump or alter the ph of the liquid.Do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.Do no submerge the battery pack in liquid.Use caution when removing batteries.The battery pack contains alkaline batteries.Exposure to the contents of an open or leaking battery or their combustion products could be harmful.Avoid skin and eye contact.Use neoprene or natural rubber gloves and safety glasses with side shields when handling batteries.Recommended actions: with the initiation of the capa, no additional internal zimmer actions are warranted at this time.

• Brand Name: HIP KIT
• Type of Device: HIP KIT
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: david bailey ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 5876909
• MDR Text Key: 53078295
• Report Number: 0001526350-2016-00085
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00515048201
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1